Article 16 — Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16… · Lexiara

Article 16

Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance · European Union

In order to obtain an authorisation, the sponsor shall submit an application dossier to the Member States concerned through the EU portal.

← art_15__text_1 · All articles · art_16__text_1 →

Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.